A Palestinian medic administers a dose of the Pfizer-BioNTech COVID vaccine during an inoculation campaign at a medical center in Gaza City on Aug. 23.
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The Food and Drug Administration has given its full approval of the Pfizer-BioNTech COVID-19 vaccine, calling it a "key achievement for public health."
The two-dose vaccine is now fully approved for people ages 16 and older. For those who are ages 12 to 15 and for those who are immunocompromised and need a booster shot, the vaccine is still available under an FDA emergency use authorization.
The approval, says the FDA, means "the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."
How does a drug get final FDA approval?
Back in December 2020, the FDA allowed the Pfizer vaccine to be used under an emergency use authorization. Pfizer and BioNTech applied for full approval in May.
Now that it has gone through a full review by a U.S. regulator, this final stamp of approval means the Pfizer vaccine can now be marketed with other approved vaccines and drugs.
The process of final approval, outlined by the FDA, requires an analysis of the drug"s benefits that also examines its risks and looks at clinical trials from the drugmaker. Much of this was already done when the FDA authorized the vaccine"s emergency use.
But among the measures the FDA required for full approval that weren"t required for emergency use were data on how people fared six months after being fully vaccinated. The FDA also inspected manufacturing facilities in the intervening months.
The final approval also means the Pfizer vaccine gets a brand name: Comirnaty (it"s pronounced koe-mir"-na-tee, according to the FDA).
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Should kids under age 12 still not get vaccinated?The FDA still does not recommend that children under age 12 get the Pfizer vaccine.
Janet Woodcock, the acting FDA chief, said it "would be a great concern" for children under 12 to get the vaccine, as the FDA does not have the data on what the proper dosage would be or data on the safety of the vaccine for younger kids.
"They are not just small adults. We have learned that time and time again," she said.
Peter Marks, the director of the FDA"s Center for Biologics Evaluation and Research, said that trials regarding vaccinating children under 12 are still ongoing and that the FDA is waiting for data to be submitted.
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The American Academy of Pediatrics also warned doctors not to give vaccines to children under 12 until authorized by the FDA.